|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INSTRUCTIONS: Use this form when a single information collection document involves multiple reporting and recordkeeping requirements. The totals of the figures in cols. should be entered in item 13 of OMB-83-1: cols. (D) &/or (I) = 13a (respondent is only counted once); cols. F & I = 13b; cols. H & K = 13c. (F)Total/(D)Total = (E)Average (H)Total/(F)Total = (G)Average (K)Total/(I)Total = (J)Average
NOTE: The columns will calculate automatically. If Col. E's response is something other than annually, i.e., 1/6 years, list as "1/6" & decimal will display.
|
TITLE OF INFORMATION COLLECTION DOCUMENT |
OMB NO. |
|
|
|
|
|
|
|
|
| Select Agent Registration |
0579-0213 |
|
|
|
|
|
| DATE PREPARED |
|
|
|
| October 5, 2012 |
| IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT |
|
ANNUAL BURDEN |
|
|
|
|
|
|
|
|
REPORTS |
RECORDS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL |
|
|
|
|
|
|
FORMS NO (S) |
NO. OF |
NO OF |
TOTAL ANNUAL |
HOURS |
TOTAL |
NO. OF |
ANNUAL |
RECORD- |
| SECTION OF |
DESCRIPTION |
(If "none" |
RESPONDENTS |
RESPONSES |
RESPONSES |
PER |
HOURS |
RECORD- |
HOURS PER |
KEEPING HOURS |
| REGS. |
|
|
|
|
|
so state) |
|
PER |
(Col. D x E) |
RESPONSE |
(Col. F x G) |
KEEPERS |
RECORD- |
(Col. I x J) |
|
|
|
|
|
|
|
|
RESPONDENT |
|
|
|
|
KEEPER |
|
| (A) |
(B) |
(C) |
(D) |
(E) |
(F) |
(G) |
(H) |
(I) |
(J) |
(K) |
| 121.10, 331.10 |
Request for Expedited Access Approval Review (business) |
Letter |
2 |
1.00 |
2.00 |
3.00 |
6 |
|
|
0.00 |
|
(State and local government) |
|
1 |
1.00 |
1.00 |
3.00 |
3 |
|
|
0.00 |
| 121.7, 331.7 |
Application for Registration for Possession, Use and Transfer of Select Agents and Toxins (business) + (not-for-profit) |
APHIS/CDC 1 |
11 |
1.00 |
11.00 |
11.80 |
130 |
|
|
0.00 |
|
(State and local government) |
|
12 |
1.00 |
12.00 |
11.80 |
142 |
|
|
0.00 |
| 73.7; 121.7; and 331.7 |
Amendment to the Application for Registration (Not-for-Profit) |
1 |
163 |
3.00 |
489.00 |
1.00 |
489 |
|
|
0.00 |
| 73.7; 121.7; and 331.7 |
Amendment to the Application for Registration (Business) |
1 |
54 |
3.00 |
162.00 |
1.00 |
162 |
|
|
|
| 121.16, 331.16; 73.16; 121.16; and 331.16 |
Request to Transfer Select Agents and Toxins (business) + (not-for-profit) |
APHIS/CDC 2 |
190 |
1.00 |
190.00 |
2.00 |
380 |
|
|
0.00 |
|
(State and local government) |
2 |
278 |
1.00 |
278.00 |
2.00 |
556 |
|
|
0.00 |
| 121.16 |
Report of Transfer of Proficiency Test (business) + (not-for-profit) |
None |
2 |
1.00 |
2.00 |
1.00 |
2 |
|
|
0.00 |
|
(State and local government) |
|
1 |
1.00 |
1.00 |
1.00 |
1 |
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUBTOTAL |
|
|
|
1,148.00 |
|
1,870 |
0.00 |
|
0.00 |
|
TOTAL OF ALL PAGES |
|
|
|
4,458.00 |
|
12,220 |
296.00 |
|
148.00 |
| TOTAL - COLUMNS "F" AND "I" = OMB 831, 13 b; COLUMNS "H" AND "K" = OMB 831, 13c |
|
|
|
4,754.00 |
|
12,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INSTRUCTIONS: Use this form when a single information collection document involves multiple reporting and recordkeeping requirements. The totals of the figures in cols. should be entered in item 13 of OMB-83-1: cols. (D) &/or (I) = 13a (respondent is only counted once); cols. F & I = 13b; cols. H & K = 13c. (F)Total/(D)Total = (E)Average (H)Total/(F)Total = (G)Average (K)Total/(I)Total = (J)Average
NOTE: The columns will calculate automatically. If Col. E's response is something other than annually, i.e., 1/6 years, list as "1/6" & decimal will display.
|
TITLE OF INFORMATION COLLECTION DOCUMENT |
0579-0213 |
|
|
|
|
|
|
|
|
| Select Agent Registration |
|
|
| DATE PREPARED |
|
|
|
| October 5, 2012 |
|
| IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT |
|
ANNUAL BURDEN |
|
|
|
|
|
|
|
|
REPORTS |
RECORDS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL |
|
|
|
|
|
|
FORMS NO (S) |
NO. OF |
NO OF |
TOTAL ANNUAL |
HOURS |
TOTAL |
NO. OF |
ANNUAL |
RECORD- |
| SECTION OF |
DESCRIPTION |
(If "none" |
RESPONDENTS |
RESPONSES |
RESPONSES |
PER |
HOURS |
RECORD- |
HOURS PER |
KEEPING HOURS |
| REGS. |
|
|
|
|
|
so state) |
|
PER |
(Col. D x E) |
RESPONSE |
(Col. F x G) |
KEEPERS |
RECORD- |
(Col. I x J) |
|
|
|
|
|
|
|
|
RESPONDENT |
|
|
|
|
KEEPER |
|
| (A) |
(B) |
(C) |
(D) |
(E) |
(F) |
(G) |
(H) |
(I) |
(J) |
(K) |
| 121.19, 331.19 |
Report of Theft, Loss, or Release of Select Agent and Toxins (business) + (not-for-profit) |
APHIS/CDC 3 |
116 |
1.00 |
116.00 |
1.50 |
174 |
|
|
0.00 |
|
(State and local government) |
|
94 |
1.00 |
94.00 |
1.50 |
141 |
|
|
0.00 |
| 121.4.5.6.9, 331.5, 9 |
Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen (business) + (not-for-profit) |
APHIS/CDC 4 A, B, and C |
94 |
1.00 |
94.00 |
1.00 |
94 |
|
|
0.00 |
|
(State and local government) |
|
93 |
3.00 |
279.00 |
1.00 |
279 |
|
|
0.00 |
| 121.5, 331.5 |
Request for Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product (business) + (not-for-profit) |
APHIS CDC/5 |
2 |
1.00 |
2.00 |
1.00 |
2 |
|
|
0.00 |
|
(State and local government) |
|
1 |
1.00 |
1.00 |
1.00 |
1 |
|
|
0.00 |
| 121.8, 331.17 |
Appeal of Registration Denial, Surrender of Registration Certificate (business) + (not-for-profit) |
Letter |
2 |
1.00 |
2.00 |
1.00 |
2 |
|
|
0.00 |
|
(State and local government) |
|
1 |
1.00 |
1.00 |
1.00 |
1 |
|
|
0.00 |
| 121.9, 331.9 |
Request of ID Select Agents or Toxins Contained in Specimens Presented for Diagnosis or Verification (business)+ (not-for-profit) |
Letter |
4 |
1.00 |
4.00 |
1.00 |
4 |
|
|
0.00 |
|
(State and local government) |
|
2 |
1.00 |
2.00 |
1.00 |
2 |
|
|
0.00 |
|
SUBTOTAL |
|
|
|
595.00 |
|
700 |
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INSTRUCTIONS: Use this form when a single information collection document involves multiple reporting and recordkeeping requirements. The totals of the figures in cols. should be entered in item 13 of OMB-83-1: cols. (D) &/or (I) = 13a (respondent is only counted once); cols. F & I = 13b; cols. H & K = 13c. (F)Total/(D)Total = (E)Average (H)Total/(F)Total = (G)Average (K)Total/(I)Total = (J)Average
NOTE: The columns will calculate automatically. If Col. E's response is something other than annually, i.e., 1/6 years, list as "1/6" & decimal will display.
|
TITLE OF INFORMATION COLLECTION DOCUMENT |
OMB NO. |
|
|
|
|
|
|
|
|
| Select Agent Registration |
0579-0213 |
|
|
|
|
|
| DATE PREPARED |
|
|
|
| October 5, 2012 |
| IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT |
|
ANNUAL BURDEN |
|
|
|
|
|
|
|
|
REPORTS |
RECORDS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL |
|
|
|
|
|
|
FORMS NO (S) |
NO. OF |
NO OF |
TOTAL ANNUAL |
HOURS |
TOTAL |
NO. OF |
ANNUAL |
RECORD- |
| SECTION OF |
DESCRIPTION |
(If "none" |
RESPONDENTS |
RESPONSES |
RESPONSES |
PER |
HOURS |
RECORD- |
HOURS PER |
KEEPING HOURS |
| REGS. |
|
|
|
|
|
so state) |
|
PER |
(Col. D x E) |
RESPONSE |
(Col. F x G) |
KEEPERS |
RECORD- |
(Col. I x J) |
|
|
|
|
|
|
|
|
RESPONDENT |
|
|
|
|
KEEPER |
|
| (A) |
(B) |
(C) |
(D) |
(E) |
(F) |
(G) |
(H) |
(I) |
(J) |
(K) |
| 121.17, 331.17 |
Recordkeeping (business) |
None |
|
|
0.00 |
|
0 |
169 |
0.500 |
85 |
| 121.17, 331.17 |
Recordkeeping (State) |
None |
|
|
0.00 |
|
0 |
127 |
0.500 |
64 |
| 121.18, 331.18 |
Inspection of Facilities (business) + (not-for-profit) |
None |
33 |
cbsickles:
1.00 |
33.00 |
8.00 |
264 |
|
|
0.00 |
|
(State and local government) |
None |
42 |
1.00 |
42.00 |
8.00 |
336 |
|
|
0.00 |
| 121.6 |
Application for Permit to Import or Transport Controlled Material or Organisms or Vectors (business) |
VS 16-3 |
941 |
1.00 |
941.00 |
1.60 |
1,506 |
|
|
0.00 |
| 121.16 |
Additional Information for Cell Cultures and their Products (business) |
VS 16-7 |
1 |
1.00 |
1.00 |
0.33 |
1 |
|
|
0.00 |
| 331.16 |
Application and Permit to Move Live Plants or Noxious Weeds (business) |
PPQ 526 |
18 |
1.00 |
18.00 |
0.17 |
3 |
|
|
|
| 73.11; 121.11; and 331.11 |
Security Plan (State) |
none |
163 |
1.00 |
163.00 |
5.00 |
815 |
|
|
0.00 |
| 73.11; 121.11; and 331.11 |
Security Plan (Not-for-Profit) |
none |
163 |
1.00 |
163.00 |
5.00 |
815 |
|
|
0.00 |
| 73.11; 121.11; and 331.11 |
Security Plan (Business) |
none |
54 |
1.00 |
54.00 |
5.00 |
270 |
|
|
0.00 |
|
SUBTOTAL |
|
|
|
1,415.00 |
|
4,010 |
296 |
|
148.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INSTRUCTIONS: Use this form when a single information collection document involves multiple reporting and recordkeeping requirements. The totals of the figures in cols. should be entered in item 13 of OMB-83-1: cols. (D) &/or (I) = 13a (respondent is only counted once); cols. F & I = 13b; cols. H & K = 13c. (F)Total/(D)Total = (E)Average (H)Total/(F)Total = (G)Average (K)Total/(I)Total = (J)Average
NOTE: The columns will calculate automatically. If Col. E's response is something other than annually, i.e., 1/6 years, list as "1/6" & decimal will display.
|
TITLE OF INFORMATION COLLECTION DOCUMENT |
Page |
|
|
|
|
|
|
4 |
| Bioterrorism Protection Act of 2002; Bienniel Publication of the Select Agent and Toxin List; Regulatory Amendments |
OMB NO. |
|
|
|
| 0579-0213 |
|
| DATE PREPARED |
|
|
|
| October 5, 2012 |
| IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT |
|
ANNUAL BURDEN |
|
|
|
|
|
|
|
|
REPORTS |
RECORDS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL |
|
|
|
|
|
|
FORMS NO (S) |
NO. OF |
NO OF |
TOTAL ANNUAL |
HOURS |
TOTAL |
NO. OF |
ANNUAL |
RECORD- |
| SECTION OF |
DESCRIPTION |
(If "none" |
RESPONDENTS |
RESPONSES |
RESPONSES |
PER |
HOURS |
RECORD- |
HOURS PER |
KEEPING HOURS |
| REGS. |
|
|
|
|
|
so state) |
|
PER |
(Col. D x E) |
RESPONSE |
(Col. F x G) |
KEEPERS |
RECORD- |
(Col. I x J) |
|
|
|
|
|
|
|
|
RESPONDENT |
|
|
|
|
KEEPER |
|
| (A) |
(B) |
(C) |
(D) |
(E) |
(F) |
(G) |
(H) |
(I) |
(J) |
(K) |
| 73.12; 121.12; and 331.12 |
Biosafety/Biocontainment Plan (State) |
none |
163 |
1.00 |
163.00 |
8.00 |
1,304 |
|
|
0.00 |
| 73.12; 121.12; and 331.12 |
Biosafety/Biocontainment Plan (Not-for-Profit) |
none |
163 |
1.00 |
163.00 |
8.00 |
1,304 |
|
|
0.00 |
| 73.12; 121.12; and 331.12 |
Biosafety/Biocontainment Plan (Business) |
none |
54 |
1.00 |
54.00 |
8.00 |
432 |
|
|
|
| 73.13; 121.13; and 331.13 |
Request regarding a Restricted Experiment (State) |
none |
69 |
1.00 |
69.00 |
2.00 |
138 |
|
|
0.00 |
| 73.13; 121.13; and 331.13 |
Request regarding a Restricted Experiment (Not-for-Profit) |
none |
69 |
1.00 |
69.00 |
2.00 |
138 |
|
|
0.00 |
| 73.13; 121.13; and 331.13 |
Request regarding a Restricted Experiment (Business) |
none |
22 |
1.00 |
22.00 |
2.00 |
44 |
|
|
|
| 73.14; 121.14; and 331.14 |
Incident Response Plan (State) |
none |
163 |
1.00 |
163.00 |
5.00 |
815 |
|
|
0.00 |
| 73.14; 121.14; and 331.14 |
Incident Response Plan (Not-for-Profit) |
none |
163 |
1.00 |
163.00 |
5.00 |
815 |
|
|
0.00 |
| 73.14; 121.14; and 331.14 |
Incident Response Plan (Business) |
none |
54 |
1.00 |
54.00 |
5.00 |
270 |
|
|
|
| 73.15; 121.15; and 331.15 |
Training (State) |
none |
163 |
1.00 |
163.00 |
1.00 |
163 |
|
|
0.00 |
| 73.15; 121.15; and 331.15 |
Training (Not-for-Profit) |
none |
163 |
1.00 |
163.00 |
1.00 |
163 |
|
|
0.00 |
| 73.15; 121.15; and 331.15 |
Training (Business) |
none |
54 |
1.00 |
54.00 |
1.00 |
54 |
|
|
|
|
SUBTOTAL |
|
|
|
1,300.00 |
|
5640 |
0 |
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INSTRUCTIONS: Use this form when a single information collection document involves multiple reporting and recordkeeping requirements. The totals of the figures in cols. should be entered in item 13 of OMB-83-1: cols. (D) &/or (I) = 13a (respondent is only counted once); cols. F & I = 13b; cols. H & K = 13c. (F)Total/(D)Total = (E)Average (H)Total/(F)Total = (G)Average (K)Total/(I)Total = (J)Average
NOTE: The columns will calculate automatically. If Col. E's response is something other than annually, i.e., 1/6 years, list as "1/6" & decimal will display.
|
TITLE OF INFORMATION COLLECTION DOCUMENT |
Page |
|
|
|
|
|
|
5 |
| Bioterrorism Protection Act of 2002; Bienniel Publication of the Select Agent and Toxin List; Regulatory Amendments |
OMB NO. |
|
| 0579-0213 |
|
|
| DATE PREPARED |
|
|
|
| October 5, 2012 |
| IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT |
|
ANNUAL BURDEN |
|
|
|
|
|
|
|
|
REPORTS |
RECORDS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL |
|
|
|
|
|
|
FORMS NO (S) |
NO. OF |
NO OF |
TOTAL ANNUAL |
HOURS |
TOTAL |
NO. OF |
ANNUAL |
RECORD- |
| SECTION OF |
DESCRIPTION |
(If "none" |
RESPONDENTS |
RESPONSES |
RESPONSES |
PER |
HOURS |
RECORD- |
HOURS PER |
KEEPING HOURS |
| REGS. |
|
|
|
|
|
so state) |
|
PER |
(Col. D x E) |
RESPONSE |
(Col. F x G) |
KEEPERS |
RECORD- |
(Col. I x J) |
|
|
|
|
|
|
|
|
RESPONDENT |
|
|
|
|
KEEPER |
|
| (A) |
(B) |
(C) |
(D) |
(E) |
(F) |
(G) |
(H) |
(I) |
(J) |
(K) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUBTOTAL |
|
|
|
0.00 |
|
0.00 |
0.00 |
|
0.00 |